The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based tracking system that would allow medical device manufacturers to view the progress of their premarket submissions through the FDA’s review process.
In a posting to the agency’s website in early September, the FDA says that the planned tracker system would provide manufacturers with “near real-time submission status,” regarding their submissions. At a minimum, the FDA is seeking information in connection with the following questions;
- What information would be most useful to have in tracking a premarket submission under review?
- What information or features would address a challenge that manufacturers have experienced or are experiencing with up-to-date information on the status of the FDA review process?
- What additional communications methods could be useful to receive information on the progress of a premarket submission?
Anonymous comments can be submitted to the FDA by sending an email to PremarketProgressTracker@fda.hhs.gov. The deadline for the submission of comments on the planned progress tracker is October 8, 2020.
Additional details on the FDA’s premarket progress tracker are available at the FDA website.
Leave a Reply